ASTM_E_2045_-_99_2014.pdf

Designation:E204599(Reapproved 2014)Standard Practice forDetailed Clinical Observations of Test Animals1This standard is issued under the fixed designation E2045;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice describes the terms used in observing andrecording cutaneous,gastrointestinal,respiratory,reproductive,neuromuscular,ocular,and general clinical signs of animalsundergoing toxicological testing.This practice also assists inproperly observing and assessing laboratory animals for signsof disease or adverse effects of compound administration.1.2 This practice includes codes and descriptions for a widevariety of clinical signs,anatomical locations,and otherdescriptive qualifiers,and a technique for scoring the extent orseverity of clinical signs.1.3 This practice assumes that the reader is knowledgeablein animal toxicology and related pertinent areas and is trainedin making clinical observations.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 Federal Standards:Title 40,Code of Federal Regulations(CFR),EnvironmentalProtection Agency,Subchapter E,Pesticide Programs,Part 160,Good Laboratory Practice Standards2Title 40,Code of Federal Regulations(CFR),Toxic Sub-stances Control Act,Part 792,Good Laboratory PracticeStandards2Title 40,Code of Federal Regulations(CFR),EnvironmentalProtection Agency,Part 798,Health Effects TestingGuidelines23.Significance and Use3.1 This practice pertains to all forms of toxicologicaltesting(acute,subchronic,or chronic)performed by any routeof administration(inhalation,oral,dermal,ocular,or other).3.2 The U.S.Environmental Protection Agency,GoodLaboratory Practices for Nonclinical Laboratory Studies,aslisted in 40 CFR,requires that a testing facility maintainspecific standard operating procedures(SOPs)including anSOP covering clinical observations in test animals.3.3 This practice serves as a basis for consistency in clinicalobservations.Actual procedures and forms to be used inrecording observations must be described in individual studyprotocols.4.Procedure4.1 Observe the health of an animal at a distance and of itshousing environment to gain a general impression of its health.Also note environmental factors such as temperature,humidity,ventilation,air quality and hygienic conditions.4.2 Observe each animal and note any subtle changes inanimalbehavior,physicalappearance,posture,gait,vocalization,food and water consumption,and waste produc-tion.See Section 5 for details.4.3 Observe control animals first,followed by test groups inorder of increasing level of treatment.Observe positive controlgroup,if any,last.4.4 Note any dead animals and collect necessary tissues anddata before decomposition occurs.4.5 Report animals that show signs of sickness so thatappropriate diagnosis,treatment,or euthanasia,if appropriate,can be performed.5.General Clinical Signs5.1 Note the overall activity,behavior,and condition of theanimal.Determine the hydration status by examining skinturgor,position of the eyes such as normal or sunken,mucousmembrane color,and capillary refill time.Look for asymmetryor the presence of abnormal swellings,hemorrhage or signs ofpain.1This practice is under the jurisdiction of ASTM Committee E50 on Environ-mental Assessment,Risk Management and Corrective Action and is the directresponsibility of E50.47 on Biological Effects and Environmental Fate.Current edition approved Oct.1,2014.Published December 2014.Originallyapproved in 1999.Last previous edition approved in 2009 as E2045 99(2009).DOI:10.1520/E2045-99R14.2Available from U.S.Government Printing Office,Superintendent ofDocuments,Washington,DC 20402.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.2 The following are some general conditions along withsuggested codes for record keeping that do not fall into anyspecific organ system.Refer to Annex A1 Annex A3 for adetailed listing of the codes and their descriptions.Othergeneral reference material will also be helpful.3,4,55.2.1 Activity may be described as:decreased(ACD);increased(ACI);hyperexcitable(HX);hyperactive(HYP);lethargic(LE);irritable(IRR);moribund(MB),that is neardeath;prostate(PRO),that is,exhibiting inability or unwill-ingness to maintain upright posture.5.2.2 Body condition may be described as:obese(OBS);thin(THN);decreased rectal temperature(BTD);increasedrectal temperature(BTI);hypothermia that is cold to touch(HPO);hyperthermia that is warm to touch(HPR).5.2.3 Death may